Eu Ivdr
Eu Ivd Class A
On The Market
🇭🇺 Hungary
H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials
Devices (same UDI-DI)
6
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 05999106200559
- Basic UDI-DI Code
- 59991062NormaCont56F
- Reference
- HE5504
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- NORMA Instruments Zártkörűen Működő Részvénytársaság
Additional Description
H5-Check Control Sets are intended for quality control measurements on Analyticon hematology analyzers Hemolyzer® 5 NG (open and closed mode) (HE5100 and HE5200), and serve to validate the measurement results.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010503 | MULTILEVEL BLOOD CONTROLS |
Related Devices
The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.
H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
NormaCont5+ KIT KH control blood set for 5-part differential Norma hematology analyzers - 6 high vials
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
NormaCont5+ KIT KN control blood set for 5-part differential Norma hematology analyzers - 6 normal vials
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
NormaCont5+ KIT KL control blood set for 5-part differential Norma hematology analyzers - 6 low vials
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials
Device
EU IVDR
·
Eu Ivd Class A
·NORMA Instruments Zártkörűen Működő Részvénytársaság·On the market
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).
Automatic Tissue Processor
Device
EU IVDR
·
Eu Ivd Class A
·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries
CELL COUNTING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Zhuji Zhiwei Information and Technology Ltd.·On the market
Magnetic Immunoassay System
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen BOSH Diagnostics, Ltd.·On the market
ReaScan+
Device
EU IVDR
·
Eu Ivd Class A
·Reagena Oy·On the market·32 countries
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market
Labtub
Device
EU IVDR
·
Eu Ivd Class A
·Lingen Precision Medical Products (Shanghai) Co., Ltd.·On the market